DeviceClearance

Product code DRG— Cardiovascular

ANNE One

Classification name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Device class
Class 2
Regulation
21 CFR 870.2910
Advisory panel
Cardiovascular
Total cleared
192
First cleared
Most recent

Market context for product code DRG

FDA has cleared 192 devices under product code DRG between 1977 and 2026, filed by 126 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code DRG

Adverse events under product code DRG

product code DRG
Death
5
Total
5

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code DRG

1–100 of 192

Data sourced from openFDA. This site is unofficial and independent of the FDA.